Research Spotlight

Afzal, A. M. and D. M. Meyer (2021). “The Dark Side of Chasing the Perfect Donor. Is it Time for Us to Change Cardiac Transplant Program Performance Metrics?” Transplantation 105(9): 1919-1920.

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The authors used the database from Organ Procurement and Transplantation Network (OPTN) to retrospectively evaluate pediatric heart transplant data from 2007 to 2017. The authors evaluated the association between center refusal rate (RR) and waitlist time, waitlist removal for death/clinical deterioration, posttransplant survival, and survival after listing. A total of 5552 patients were listed at 59 centers. The centers with higher RR had a shorter time to first offer, had longer waitlist time, were more likely to remove patients from the waitlist due to death or deterioration, less likely to transplant listed patients, and had a lower likelihood of survival 1 year after listing. Based on these findings, the authors concluded that patients listed at high RR centers had worse survival rates despite having shorter times for the first offer and having similar 1-year posttransplant outcomes. The authors do highlight the limitations that are inherent to doing a retrospective analysis from a national database including the concern that the accuracy of refusal codes in the database is unknown or poor in most cases. [No abstract; excerpt from article].

Pham, P. H., L. N. Stalter, E. J. Martinez, J. F. Wang, B. M. Welch, G. Leverson, N. Marka, T. Al-Qaoud, D. Mandelbrot, S. Parajuli, H. W. Sollinger, D. Kaufman, R. R. Redfield and J. S. Odorico (2021). “Single center results of simultaneous pancreas-kidney transplantation in patients with type 2 diabetes.” Am J Transplant 21(8): 2810-2823.

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Studies have found similar outcomes of Simultaneous Pancreas-Kidney transplantation (SPKT) in patients with Type 2 (T2D) and Type 1 diabetes (T1D). However, there are scarce data evaluating the association of recipient factors such as age, BMI, or pretransplant insulin requirements with outcomes, thus the criteria for the optimal recipient selection remains unclear. In this study, 284 T1D and 39 T2D patients, who underwent SPKT between 2006 and 2017 with 1 year of follow-up at minimum, were assessed for potential relationship of pretransplant BMI and insulin requirements with posttransplant diabetes and pancreatic graft failure. Kaplan-Meier analysis showed similar rates of freedom from posttransplant diabetes (94.7% T2D vs. 92.3% T1D at 1 yr, and 88.1% T2D vs. 81.1% T1D at 5 yrs) and graft survival (89.7% T2D vs. 90.4% T1D at 1 yr, and 89.7% T2D vs. 81.2% T1D at 5 yrs). There was no significant association between BMI or pretransplant insulin requirements with posttransplant diabetes occurrence in either T1D (p = .10, .43, respectively) or T2D (p = .12, .63) patients in the cohort; or with graft failure (T1D: p = .40, .09; T2D: p = .71, .28). These observations suggest a less restricted approach to selective use of SPKT in patients with T2D.

Ono, M., H. Kawashima, H. Hara, M. Mancone, M. J. Mack, D. R. Holmes, M. C. Morice, A. P. Kappetein, D. Thuijs, T. Noack, F. W. Mohr, P. M. Davierwala, Y. Onuma and P. W. Serruys (2021). “Impact of major infections on 10-year mortality after revascularization in patients with complex coronary artery disease.” Int J Cardiol Aug 8;S0167-5273(21)01223-7. [Epub ahead of print].

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BACKGROUND: The significant interaction between major infection and 5-year mortality after percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) for complex coronary artery disease (CAD) was observed previously. However, the very long-term outcomes beyond 5 years remains unclear. METHODS AND RESULTS: This is a subgroup analysis of the SYNTAX Extended Survival (SYNTAXES) trial, which is the extended follow-up of the randomized SYNTAX trial comparing PCI versus CABG in patients with three-vessel disease (3VD) or left-main CAD (LMCAD). Out of 1517 patients enrolled in the SYNTAX trial with available survival status from 5 to 10 years, 140 patients had experienced major infections and survived at 5 years (major infection group). From 5 to 10 years, the mortality of major infection group was 19.8% whereas the mortality of no major infection group was 15.1% (p = 0.157). After the adjustment of other clinical factors, the risk of mortality from 5 to 10 years did not significantly differ between major infection and no major infection groups (HR: 1.10; 95% CI: 0.62-1.96; p = 0.740). When stratified by the presence or absence of periprocedural major infections, defined as a major infection within 60 days after index procedure, there was also no significant difference in 10-year mortality between two groups (30.8% vs. 24.5%; p = 0.057). CONCLUSIONS: Despite the initial association between major infections and 5 years mortality, postprocedural major infection was not evident in the 10 years follow-up, suggesting that the impact of major infection on mortality subsided over time beyond 5 years. TRIAL REGISTRATION: SYNTAXES ClinicalTrials.gov reference: NCT03417050 SYNTAX ClinicalTrials.gov reference: NCT00114972.

Kosmidou, I., J. Lindenfeld, W. T. Abraham, M. J. Rinaldi, S. R. Kapadia, V. Rajagopal, I. J. Sarembock, A. Brieke, P. Gaba, J. H. Rogers, B. Shahim, B. Redfors, Z. Zhang, M. J. Mack and G. W. Stone (2021). “Sex-Specific Outcomes of Transcatheter Mitral-Valve Repair and Medical Therapy for Mitral Regurgitation in Heart Failure.” JACC Heart Fail 9(9): 674-683.

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OBJECTIVES: This study sought to assess the sex-specific outcomes in patients with heart failure (HF) with 3+ and 4+ secondary mitral regurgitation (SMR) treated with transcatheter mitral valve repair (TMVr) plus guideline-directed medical therapy (GDMT) versus GDMT alone in the COAPT trial. BACKGROUND: The impact of sex in patients with HF and severe SMR treated with TMVr with the MitraClip compared with GDMT alone is unknown. METHODS: Patients were randomized 1:1 to TMVr versus GDMT alone. Two-year outcomes were examined according to sex. RESULTS: Among 614 patients, 221 (36.0%) were women. Women were younger than men and had fewer comorbidities, but reduced quality of life and functional capacity at baseline. In a joint frailty model accounting for the competing risk of death, the 2-year cumulative incidence of the primary endpoint of all HF hospitalizations (HFH) was higher in men compared with women treated with GDMT alone. However, the relative reduction in HFHs with TMVr was greater in men (HR: 0.43; 95% CI: 0.34-0.54) than women (HR: 0.78; 95% CI: 0.57-1.05) (P(interaction) = 0.002). A significant interaction between TMVr versus GDMT alone treatment and time was present for all HFHs in women (HR: 0.57; 95% CI: 0.39-0.84, and HR: 1.39; 95% CI: 0.83-2.33 between 0-1 year and 1-2 years after randomization, respectively, P(interaction) = 0.007) but not in men (HR: 0.48; 95% CI: 0.36-0.64, and HR: 0.33; 95% CI: 0.21-0.51; P(interaction) = 0.16). Female sex was independently associated with a lower adjusted risk of death at 2 years (HR: 0.64; 95% CI: 0.46-0.90; P = 0.011). TMVr consistently reduced 2-year mortality compared with GDMT alone, irrespective of sex (P(interaction) = 0.99). CONCLUSIONS: In the COAPT trial, TMVr with the MitraClip resulted in improved clinical outcomes compared with GDMT alone, irrespective of sex. However, the impact of TMVr in reducing HFH was less pronounced in women compared with men beyond the first year after treatment. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Tria] [COAPT]; NCT01626079).

Shahim, B., O. Ben-Yehuda, S. Chen, B. Redfors, M. V. Madhavan, S. Kar, D. S. Lim, F. M. Asch, N. J. Weissman, D. J. Cohen, S. V. Arnold, M. Liu, J. Lindenfeld, W. T. Abraham, M. J. Mack and G. W. Stone (2021). “Impact of Diabetes on Outcomes After Transcatheter Mitral Valve Repair in Heart Failure: COAPT Trial.” JACC Heart Fail 9(8): 559-567.

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OBJECTIVES: This paper sought to determine whether diabetes influences the outcomes of transcatheter mitral valve repair (TMVr) in patients with heart failure (HF) and secondary mitral regurgitation (SMR). BACKGROUND: Diabetes is associated with worse outcomes in patients with HF. METHODS: The COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With functional Mitral Regurgitation) trial randomized HF patients with 3+ or 4+ SMR to MitraClip plus guideline-directed medical therapy (GDMT) versus GDMT alone. Two-year outcomes were evaluated in patients with versus without diabetes. RESULTS: Of 614 patients, 229 (37.3%) had diabetes. Diabetic patients had higher 2-year rates of death than those without diabetes (40.8% vs 32.3%, respectively; adjusted P = 0.04) and tended to have higher rates of HF hospitalization (HFH) (HFH: 50.1% vs 43.0%, respectively; adjusted P = 0.07). TMVr reduced the 2-year rate of death consistently in patients with (30.3% vs 49.9%, respectively; adjusted HR: 0.51; 95% CI: 0.32 to 0.81) and without (27.0% vs 38.3%, respectively; adjusted HR: 0.57; 95% CI: 0.39-0.84) diabetes (P(interaction) = 0.72). TMVr also consistently reduced the 2-year rates of HFH in patients with (32.2% vs 54.8%, respectively; adjusted HR: 0.41; 95% CI: 0.28-0.58) and without (41.5% vs 59.0%, respectively; adjusted HR: 0.54: 95% CI 0.35-0.82) diabetes (P(interaction) = 0.33). Greater movements in quality-of-life (QOL) and exercise capacity occurred with TMVr than with GDMT alone, regardless of diabetic status. CONCLUSIONS: Among HF patients with severe SMR in the COAPT trial, those with diabetes had a worse prognosis. Nonetheless, diabetic and nondiabetic patients had consistent reductions in the 2-year rates of death and HFH and improvements in QOL and functional capacity following TMVr treatment using the MitraClip than with maintenance on GDMT alone. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [COAPT]; NCT01626079).